Overview
Toremifene is a selective estrogen receptor modulator (SERM) and a nonsteroidal antiestrogen used to treat estrogen receptor positive breast cancer. Like tamoxifen, toremifene is part of the first-generation triphenylethylene derivative chemical class of SERMs. Toremifene possesses tissue-specific actions: it has estrogenic (agonist) activity on the cardiovascular system and on bone tissue and it has weak estrogenic effects on uterine tissue, however, it also has antiestrogenic (estrogen-antagonist) activity on breast tissue.
Indication
For the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor-positive or receptor-unknown tumors. Toremifene is currently under investigation as a preventative agent for prostate cancer in men with high-grade prostatic intraepithelial neoplasia and no evidence of prostate cancer.
Associated Conditions
- Metastatic Breast Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/06 | Phase 3 | Recruiting | |||
2023/04/06 | N/A | Not yet recruiting | |||
2020/12/14 | N/A | UNKNOWN | First Hospital of China Medical University | ||
2020/08/28 | Phase 2 | Withdrawn | Reena Mehra, MD | ||
2019/04/24 | N/A | UNKNOWN | Xijing Hospital | ||
2017/11/22 | Phase 3 | Recruiting | Chinese Anti-Cancer Association | ||
2017/08/03 | Phase 4 | Withdrawn | |||
2015/07/23 | Phase 2 | UNKNOWN | N.N. Petrov National Medical Research Center of Oncology | ||
2015/02/02 | Phase 2 | UNKNOWN | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||
2015/01/26 | Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Kyowa Kirin, Inc. | 42747-327 | ORAL | 60 mg in 1 1 | 7/17/2023 | |
| MSN LABORATORIES PRIVATE LIMITED | 69539-152 | ORAL | 60 mg in 1 1 | 8/20/2020 | |
| Rising Pharma Holdings, Inc. | 64980-404 | ORAL | 60 mg in 1 1 | 1/4/2019 | |
| Rising Pharma Holdings, inc. | 64980-404 | ORAL | 60 mg in 1 1 | 1/4/2019 | |
| Rising Pharmaceuticals, Inc. | 64980-404 | ORAL | 60 mg in 1 1 | 1/4/2019 | |
| Novadoz Pharmaceuticals LLC | 72205-050 | ORAL | 60 mg in 1 1 | 9/2/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/14/1996 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Toremifene Citrate Tablets | 国药准字H20253892 | 化学药品 | 片剂 | 4/15/2025 | |
| Toremifene Citrate Tablets | 国药准字H20253891 | 化学药品 | 片剂 | 4/15/2025 | |
| Toremifene Citrate Tablets | 国药准字H20243050 | 化学药品 | 片剂 | 1/16/2024 | |
| Toremifene Citrate Tablets | 国药准字HJ20130705 | 化学药品 | 片剂 | 5/10/2023 | |
| Toremifene Citrate Tablets | 国药准字H20061284 | 化学药品 | 片剂 | 4/9/2020 | |
| Toremifene Citrate Tablets | 国药准字H20020047 | 化学药品 | 片剂 | 4/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FARESTON toremifene (as citrate) 60mg tablet | 59743 | Medicine | A | 6/6/1997 |
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